Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

Cognitive Dysfunction Clinical Trial

Official title:

Effect of Intraoperative Dexmedetomidine Infusion on Early Postoperative Cognitive Dysfunction (POCD) in Geriatric Patients Undergoing Hip Surgery Under Spinal Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793751
• Other study ID #: 201-26104-172-215441
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2020
• Source: Tata Main Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years undergoing hip surgery under spinal anaesthesia.

Description:

Postoperative cognitive dysfunction (POCD) is a common postoperative neurological complication in elderly. POCD is a subtle impairment of memory, concentration and information processing with clinical manifestations of delirium, anxiety, personality changes and impaired memory, which is associated with prolonged hospitalization, a reduced quality of life and an increase in morbidity and mortality. Dexmedetomidine is a highly selective α-2 adrenergic receptor agonist with a dose-dependent sedative hypnotic effect. It has also been reported that dexmedetomidine has a potential role in preventing POCD due to its neuroprotective effects both in vitro and in vivo.

Till date very few studies have analysed the impact of dexmedetomidine on early POCD. Even in the few available studies compared assessment of POCD using the Mini-Mental State Examination (MMSE) scores and found that MMSE have lower sensitivity for identifying Cognitive Dysfunction as compared to Montreal Cognitive Assessment (MoCA). The study would analyze the impact of Intraoperative Dexmedetomidine infusion on early Postoperative Cognitive Dysfunction (POCD) in geriatric patients above 60 years undergoing hip surgery under spinal anesthesia.

So this study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years undergoing hip surgery under spinal anaesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• American society of Anesthesiology (ASA) status of I-III

• Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia

Exclusion Criteria:

• Patient not willing to be a part of the study

• Patients were aged <60 or >75 years

• Patients with accompanying medical conditions that may affect the level of consciousness, such as stroke, stupor or dementia, or patients with abnormalities in hepatic or renal function, electrolyte imbalance

• Patients suffering from preoperative bradycardia [heart rate (HR) <60 bpm] or hypotension [mean arterial blood pressure (MAP) <70 mmHg]

• Patients who had recently received a sedative or opioid drug

• Patients with a MoCA (Montreal Cognitive Assessment) score <26

• Patients with persistent hypotension and bradycardia intra-operatively even after giving Mephentermine will be excluded from the study

Related Conditions & MeSH terms

• Cognitive Dysfunction

Intervention

Drug:
• Dexmedetomidine Injection
Dexmedetomidine Injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.

Locations

Country	Name	City	State
India	Dr.Deb Sanjay Nag	Jamshedpur	Jharkhand

Sponsors (1)

Lead Sponsor	Collaborator
Tata Main Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cases Developing POCD	Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The "Montreal Cognitive Assessment" (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.	0-7 days
Secondary	Systolic Blood Pressure	Intraoperative Systolic Blood Pressure	Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
Secondary	Diastolic Blood Pressure	Intraoperative Diastolic Blood Pressure	Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
Secondary	Heart Rate	Intraoperative Heart Rate	Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
Secondary	Any Adverse Outcome	Observation for any adverse effects	0-7 days